What are the biggest challenges for brokers when it comes to serialisation?

Adrián Abad Fustero, supply chain director of Medis, will be presenting at FutureLink Munichon the ‘The Virtual Broker: Negotiating Win-Wins with Track & Trace Partners’. In a preview of his presentation, we interviewed Fustero on the role of brokers in Falsified Medicines Directive (FMD) serialisation programmes.

Negotiations

Middle brokers have a unique challenge when it comes to serialisation. They have vested interests in both marketing authorisation holders (MAHs) and contract manufacturers (CMOs) and must understand everything to be able to support compliance efforts throughout the supply chain.

There are three pillars of serialisation programmes where input from brokers is essential.

Master data management and verification

In a serialised environment, master data is key, and a lot of work is required to produce and communicate the right data. Businesses simply can’t do it alone and brokers need to work closely with their customers to implement effective master data management processes.

Artwork processes

Even in the EU, where there is a singular regulation, every country has autonomy to interpret requirements as they see fit. Brokers need to understand each market and the different artwork layouts to support serialisationand educate customers in this area.

IT connectivity

Managing the way data is exchanged between site systems, enterprise systems, partners and with the EU hub is the most fundamental requirement of serialisation. Brokers need to effectively communicate how this is going to be achieved between all their partners. A validated network-tenant approach is preferred.

Most importantly, brokers must always work to understand what their customers need and offer pragmatic guidance and education while being proactive with problems.

Q. In TraceLink’s Global Drug Supply, Safety and Traceability (GDSST) Survey, not one of the EU FMD pharma respondents who feel ‘very ready’ for European serialisation requirements are fully integrated with their CMOs whereas 73% of CMOs stated they were connected with their brand owner customers. What do you think has caused this disparity?

A. MAHs and CMOS have a different understanding of the concept of ‘fully integrated’. For some businesses, it means that internal lines are ready, and they have invited partners to begin the onboarding process, for others, it means that they are already serialising products with an EU partner.

CMOs often believe they are ready once the equipment installation is complete, but, full serialisation onboarding is much more than that. There is a big collaboration needed between the MAHs and CMOs.

Transparency is essential as it will help streamline onboarding processes and any other negotiations. Priority must be given to the technical and delivery teams with commercial elements a secondary consideration due to the relatively short deadlines.

Q. Also in the survey, 30% of EU FMD pharma companies had already hired additional staff dedicated to serialisation compared to 9% of US Drug Supply Chain Security Act (DSCSA) companies at the same point in their preparations. Do you think pharma companies should look to third-party specialists to fill resource gaps or recruit in-house? Why?

A. Businesses should audit their internal capabilities and outsource specialised serialisation knowledge.Serialisation is something relatively new in pharma and requires technical knowledge that many organisations lack. Nonetheless, serialisation impacts every department, which requires continuous learning from staff and expertise throughout.

Serialisation is considered a top priority due to Medis’ huge generic portfolio and the potential impact of FMD on the business. Very early on, we assessed and budgeted for the necessary internal and external resources to manage a serialisation project.

Q. What do you think the next technical innovation in the pharmaceutical industry will be? What will be the next big change?

A. Making better use of big data to deliver personalised solutions to patient diseases in a much more targeted way is the pharma industry’s next hurdle.

The industry is still running behind other sectors and we are seeing now that many of the projects already implemented in said sectors are now being rolled out in the pharma industry. Process automation and digitisation will both increase visibility of supply chain operations and allow businesses to create efficiency, which will reduce costs and batch release time.

Q. Are there any technologies driving significant change currently outside of serialisation?

A. Businesses should always be looking at what’s next and suppliers must similarly be continuously exploring ways to add value for their customers. Medis, for example, is always working to automate processes on the back of greater digitisation.

Medis has also created a customer portal which doubles as an educational and project management tool. Customers can access info from the European Medicines Verification Organisation (EMVO), updates on new legislation, contact information and member state artwork updates. These kinds of centralised reference tools will help businesses to develop holistic views of their supply chain and markets.

Q. What opportunities will digitisation and big data present pharma businesses in the future?

A. A company investing in digitisation and big data will be able to reduce mistakes and make more accurate decisions. Furthermore, serialisation is forcing companies to generate an extensive network and communicate huge volumes of valuable data with partners throughout the supply chain, this creates a foundation for new digitisation projects that will fundamentally change the industry. Ultimately, better use of data will lead to safer and more effective treatments for patients.

Adrián Abad Fustero, Supply Chain Director at Medis, will be speaking at FutureLink Munich, which will take place 6–7 June 2018. Designed for both commercial and operational executives from the pharmaceutical and healthcare industries, FutureLink will deliver two separate tracks customised for executives with interests in regulatory compliance or commercial initiatives.